The organization must determine and provide the resources needed to implement a quality management system, to maintain its effectiveness continually, and to meet customers' requirements as well as regulatory requirement.

Chapter 6 deals with resources required to establish and maintain a quality management system according to the requirements in presented in the Standard (the 9001 or the 13485). The ISO standard, actually, requires that the organization shall define the required resources in order to maintain a quality management system appropriate to the standard requirements. The ISO Standard does not require documenting the resources required to maintain the quality management system. Defining the requirements but not documenting them?!? Again the standard puts us a challenge. We say forget about the challenge. Just document and move on…

ISO 13485 requires that the organization not only provide the resources to implement the quality management system but provide any resources required to maintain its effectiveness. What is the difference between the ISO 9001? The ISO 9001 Standard requires to continually improving you quality management system by providing resources while 13485 requires maintaining the effectiveness by providing resources. Still, what is the difference?  One of 13485 requirements is to maintain procedures to ensure effectiveness of the quality management system. We will get there soon. Have no worries. Meanwhile, in paragraph 6.1 the organization is required to define and provide the resources that would achieve the effectiveness. So, when you are planning how to achieve effectiveness make sure you remember to include the resources. If the effectiveness would be measured as reduction of customer's medical device returns (god forbidden) then you are required to include the aspect of resources: substructure, human resources etc.
The next requirements refer to customer and regulatory requirements. While The ISO 9001 Standard requires to provide resources in order to enhance customers' requirement, his cousin, the ISO 13485 Standard requires that the organization shall provide resources to meet customers' requirement and (more important and constantly repeated) to meet regulatory requirements. The 13485 give a large scale to any regulatory requirement required to produce the product as well as standard requirement. So, when planning and documenting your resources (human and substructures) you required to consider deeply any regulatory requirements and follow. When these requirements are regulatory requirements (for example, in Israel) the organization would be required to present the employee and his certification as well. They would have the same scale as the ISO 13485 Standard requirements.

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